CN110996777A - An intraoral medical device for predicting oral cancer, malignant disease, dental caries and periodontal pocket abnormality - Google Patents

Abstract

A handheld medical device having a light emitting source and a CCD camera for viewing the oral cavity for intraoral screening of diseases such as oral cancer and Potentially Malignant Disease (PMD). The device has an illumination source of various wavelengths, a selector switch (capable of exciting light of a particular wavelength from the illumination source), a switch for adjusting the intensity of light of various wavelengths emitted from the illumination source, an electronic system to control the selector switch and illumination source, and a camera to transmit and capture stored and real-time images from the oral cavity.

Description

An intraoral medical device for predicting oral cancer, malignant disease, dental caries and periodontal pocket abnormality

Cross reference to related applications and priority claims

This application claims priority to indian patent application No.201741028952 filed on 8/16/2017, the entire contents of which are incorporated herein by reference.

Technical Field

The present invention relates to an intraoral medical device ("DR Oroscope") for diagnosing oral abnormalities. More particularly, the present invention relates to an economical fluorescence visualization device using various wavelengths of light to detect abnormal oral tissue not seen by natural white light. The device will also help detect tissue vascularity and infection in the oral cavity.

Background

Spectroscopic devices and endoscopes are widely used as tissue optics based imaging devices for screening and diagnosis. Tissue optics refers to the effect of light on living tissue. In the identification of oral cancer, blue light (wavelength 400-. This technique is particularly useful when the blue light penetrates approximately 1 mm deep, and over 95% of all oral cancers are squamous cell carcinomas. The thickness of the epithelium ranges from 99um at the base of the mouth to 294um at the buccal mucosa, so that 400-490nm blue light can easily reach this layer of the skin.

Tumors tend to exhibit lower levels of autofluorescence due to their increased metabolic activity compared to healthy tissue. This increase in metabolic activity leads to the breakdown of extracellular matrix and a decrease in the concentration of Flavin Adenine Dinucleotide (FAD). FAD is a fluorophore and an endogenous compound, excited at 430 nm. It absorbs blue light and emits green light. However, the areas with lower FAD concentration will emit less green light, so that FVL can be observed.

Light of blue, green and yellow wavelengths is best absorbed by hemoglobin. Tumor tissue shows increased blue light absorption and scattering due to the increased number of blood vessels in the tumor compared to normal healthy tissue. Thickening of the epithelium, increased vascularization and dysplastic nuclei are all caused by the progression of the tumor. These factors also lead to absorption and/or scattering of light.

Cancer is one of the leading causes of death worldwide; oral cancer is the sixth most common cancer in asia, ranked third among all cancers in india. Oral cancer is more prevalent in the population starting from the lower socioeconomic scale, india accounts for 1/3 of the worldwide oral cancer cases. In most cases, oral cancer has the aforementioned PMD. When identified by screening a larger population at this stage, progression can be controlled, thereby reducing the incidence of oral cancer.

Regular screening and early diagnosis of cancer will greatly increase the chances of successful treatment and improve the health care effects. Although the use of a fixed screening schedule is suggested in certain types of cancer, some screening techniques are still evolving with the continued search for early cancer diagnostic methods, including the search to identify new biomarkers, as described in U.S. patent 20110021370.

For the purpose of such screening, many point-of-care and portable devices are being developed and used in the clinic. U.S. patent No. 9535068 discloses a point-of-care diagnostic test, apparatus and disposable for determining a patient's risk of oral cancer in the same visit in which the sample is collected.

VELscope is a device that can increase the percentage of cancer detected by displaying oral cancer that is not discernible to the naked eye during standard examinations, and cannot be used in low-resource environments due to economic limitations based on device cost and the sensitivity of many such devices that remains low.

Various other patents US9125610, US20060241347, US20080318180 describe devices that can be used for oral screening, but lack a multi-wavelength illumination (light emitting) source capable of identifying abnormal new vasculature and infection. These devices also lack an image sensor, and therefore they cannot visualize the edges of a lesion or any PMD.

Some existing technologies and apparatuses for oral cancer detection have the following advantages and disadvantages:

therefore, there is a need to develop a low-cost device with higher sensitivity and specificity for screening oral cancer, and the "DR Oroscope" of the present invention can revolutionize early cancer detection.

Disclosure of Invention

The present invention relates to a handheld intraoral medical device having an illumination source that emits light of various specific wavelengths for screening various oral diseases because abnormal tissue and dysplastic changes are not visible under a single light source that produces white light. Embodiments of the present invention provide a cost effective device to diagnose abnormalities in the oral cavity, potentially malignant diseases, interdental caries, periodontal pockets and other such diseases. The device also utilizes various wavelengths of light emitted from the light emitting source to aid in the observation of vasculature in the lesion and possible infection in the oral cavity.

Embodiments of the invention are described having a proximal end, a body, and a distal end or tail of the device. The proximal end has a light source and a CCD sensor based camera and filter mechanism that is miniaturized for intraoral use. The distal end has a power mechanism. The handheld body has the core of a system that includes a microprocessor-based circuit with embedded software to capture and transmit images/video; a plurality of switches control the wavelength, intensity and recording mechanism. The captured images/video are further processed using image/video processing software and displayed on a suitable device (e.g., a smartphone or smart tablet or computer) for medical diagnosis to detect oral abnormalities.

Drawings

The detailed description is described with reference to the accompanying drawings. The left-most digit(s) of a reference number identifies the figure in which the reference number first appears. Throughout the drawings, the same reference numerals are used to designate similar features and components.

FIG. 1: top view of the apparatus

FIG. 2: oblique view of the device

FIG. 3: top view of a PCB in a device

FIG. 4: side view of Printed Circuit Board (PCB)

FIG. 5: the fibrosis of the oral mucosa observed under natural light (A) and extraoral blue light (B) was compared with OraliD (C)

FIG. 6: the case of photographs taken with natural light (a), filtered photographs taken with natural light (B), filtered photographs taken with blue light (C), filtered photographs taken with blue light (D)

FIG. 7: block level description of DR Oroscope System

The drawings may show only those specific details that are pertinent to understanding the embodiments of the present invention. Furthermore, skilled artisans will appreciate that elements in the figures are illustrated for simplicity and may not necessarily be drawn to scale.

Detailed Description

Unless the context or definition indicates otherwise, all terms used herein (including those specifically described below in this section) are used in their ordinary sense. Also, unless otherwise specified, the use of "or" includes "and vice versa, except in the claims. Non-limiting terms are not to be construed as limiting unless explicitly stated otherwise (e.g., "including" and "comprising" mean "including but not limited to" unless explicitly stated otherwise).

The present invention is a medical device of portable design and for intraoral use. The described apparatus is divided into three sections:

a. a proximal end or head (1) of the device;

b. a main body (2) of the device and

c. the distal or tail portion (3) of the device.

The proximal end of the device includes a light source (6) and a charge coupled device sensor with a camera and filter mechanism (5).

The light source (6) of the present embodiment has a Light Emitting Diode (LED) lamp, and the support drive circuit may emit light of various wavelengths to illuminate the suspicious region, and the emitted light produces a light signal that illuminates the target region. An optional filter may be used in conjunction with the light source to control the light parameters. Unlike existing devices which can only be effectively visualized in dark rooms, light of various wavelengths enables the oral cavity to be viewed in daylight or in light rooms. It has been observed that light of various wavelengths is helpful for specific diagnostics in the oral cavity. The invention emits light with three different wavelengths; they are blue, red and green amber.

Blue light is used to detect potentially malignant diseases and oral cancers based on the autofluorescence and loss of fluorescence properties of the tissue.

Red light is used to detect infections that occur in various situations.

Green amber light is used to detect blood vessels, as increased necrosis of peripheral vessels and the center is a significant feature of malignancies. This light can also be used with the blue light described above to detect prognosis.

A charge-coupled device (CCD) sensor (5) based camera, optical focus and filter mechanism (5) is adjacent to or within the light emitting area for capturing images/video of the oral cavity. The CCD sensor (5) is used to capture images by switching various light wavelengths without moving the device, thereby contributing to standardization. An intra-oral device may be attached to communicate with an external device such as a smart mobile phone, smart tablet, computer, or any other device for storing, processing, and displaying images/video. A filter can be fixed to the CCD sensor (5) that selectively blocks light of a particular wavelength from entering the sensor. This blocking of the optical inspection signal from the light source results in a different signal, which is captured by the image sensor. The CCD sensor (5) captures the light signal and the intra-oral device transmits the image data to application software on the smart device or computer which can perform image processing, such as filtering and sharpening images with low or excessive light to enhance sharpness. This improves the accuracy of capturing all areas of the mouth including the lesion margins.

The device also includes a filter that can be incorporated into the CCD sensor (5) camera mechanism. This makes the intraoral device more economical to manufacture and use in low-to-medium income countries when the filtering operation is done using external image processing software.

The body of the device (2) includes a plurality of switches (4) in a plurality of positions to control the activation of the light source, the wavelength and intensity of light emitted from the light source and the recording mechanism (6). The body of the device connects the proximal (1) and distal (3) ends of the device and is the area used by the user to hold the device. The body of the device also comprises a printed circuit board (7) which mechanically supports and electrically connects the electronic components of the device. The PCB (7) can be made rigid or flexible-rigid or flexible on any substrate. The body and proximal end of the device may be designed to be made rigid or flexible.

The body of the device contains the core of the system, as shown in the block diagram of fig. 7. This can be understood by those skilled in the art of designing electronic embedded systems and IoT (internet of things). The present embodiment is based on a microprocessor with a memory and an input/output mechanism. The embodiments may alternatively be implemented on an ASIC or FPGA or microprocessor or a combination thereof. The microprocessor executes embedded software stored in a memory-PROM (programmable read only memory). There may be other storage means (NAND flash or SD card) to store the image in the intraoral device if desired for later use. The microprocessor interfaces with the light source driver, tunable filter, CCD sensor circuit, optical focusing mechanism, input mechanism using switches (for light source profiles) and data transfer communication means (e.g. USB port or fiber optic port or bluetooth or WirelessLAN or cellular communication). The core of the system is not necessarily limited to a position in the apparatus main body (2). It can be located anywhere throughout the intraoral device, depending on the mechanical design, as long as space and heat dissipation are concerned. The device may have an optional battery for an independent power source, otherwise it may draw power from an externally connected device.

The remote end of the device (3) is used for the power subsystem of the device to power the PCB circuitry and interface to an external computing system, such as a smart device or computer or any such related device, to capture and process images/video. The remote end may have a power subsystem with a battery or cable mechanism to provide power when connected to the smart device or computer or any such related device. The power subsystem need not be limited to the distal end (3) of the device and can be located anywhere in the overall intraoral device mechanical design, as long as space and power supply heat dissipation are concerns. The intra-oral device may also be connected to an external computing system, such as a smart device or a computer or any such related device, through a wired or wireless data communication network subsystem. When connected through a data communication network (internet cloud), the present invention can transmit real-time and stored images to a smart device or computer or any such related device that can make remote diagnosis by using "DrOrospope".

The device of the invention is made of a material such as plastic or any polymer or thermoplastic or resin or mixtures thereof. The term "plastic" means a material composed of any of a variety of synthetic or semi-synthetic organic compounds that are malleable and can be molded into a solid. It belongs to a variety of polymers such as polyamide or nylon, polycarbonate, polyester, polyethylene, polyvinyl chloride, polyvinylidene chloride, acrylonitrile butadiene styrene, or combinations thereof. The device may be a molded polymer (e.g., a body of thermoplastic material) that may be made of a single layer of polymeric (plastic) material. The material used to form the container body may be selected such that the container body is visually transmissive and substantially impermeable at normal ambient pressures, thereby allowing for a suitable shelf life. Unlike conventional containers, the container body need not have the necessary characteristics to be autoclaved (e.g., withstand the high temperatures, pressures, and vapors of autoclaving). Examples of useful materials include, but are not limited to, polycarbonate, polyolefin (e.g., polypropylene (PP), Polyethylene (PE), or Cyclic Olefin (COC)), polyester (e.g., polyethylene terephthalate (PET) or polyethylene naphthalate (PEN)), polyamide (nylon), or other well-known materials in the plastic arts. Among polyethylene, LDPE (low density polyethylene) and HDPE (high density polyethylene) may be used as the polymer. Amorphous plastics exhibiting high transparency, such as amorphous nylon, may also be suitable.

The device operates on the basis of fluorescence activity and uses various wavelengths of light to view the oral cavity by penetrating the epithelial tissue and passing through the basal layer to the stroma. This would enable the user to observe a suspicious lesion in different colors, since green light would make the vasculature in the lesion visible, while in cancerous tissue this vasculature is increased, while red light would make any infection in the oral cavity visible. The apparatus of the present invention is superior to other apparatuses in the following points:

1. portability: an intra-oral portable device.

2. And (3) connectivity: can be connected to any smart device, such as a cell phone or tablet; computers and related devices. The device may draw power from the devices to operate, thereby enabling further use thereof in low resource environments. The images may be transmitted to these external devices through a wired connection such as a USB or optical fiber cable, or through a wireless connection such as a WirelessLAN or bluetooth or related programs, or through a data communication network to provide telemedicine-based services.

3. Visibility: data transmitted from the intraoral device camera to a smart device (e.g., cell phone, computer, and related devices) may provide greater oral visibility, further facilitating better examination and screening. A camera integrated into the device assists the user in capturing images while performing the examination.

4. Reproducibility: high magnification and repeat photographs can be taken.

5. Load bearing capacity: the equipment has low manufacturing cost and is suitable for being used in countries with low and medium income.

6. Acceptability: higher because it is a non-invasive inspection technique.

7. The accuracy is as follows: accuracy is improved due to the generation of light of different wavelengths and intensities.

8. Accessibility: can be used as an intraoral device to enter each corner of the oral cavity, and can be used by any medical personnel anywhere.

Experiment:

the primary screening was performed by screening 100 patients with oral diseases. Personal information, social information, past medical history, patient habits, and additional information for the visit are recorded. The collected medical history helps to determine whether intraoral lesions are likely to be part of a systemic disease, and the course of treatment that needs to be provided to the patient. The patients were thoroughly examined with the "DR Oroscope" system of the present invention. Two examinations were performed on the potential malignant lesions observed for each patient: the first examination consisted of screening the oral cavity with a DR Oroscope device and then biopsy the lesion to confirm the pathology. When examining using DR Oroscope, the examination will be done using blue, green and red light in sequence to view the entire mouth of the patient at all these wavelengths of light. Fig. 5 shows the inspection under natural light (a), using blue light of DR Oroscope (B) and another commercially available device oralcid (c). Neovasculature and lesions were clearly more distinct when observed using DR Oroscope. Fig. 6 shows the case of examination under natural light (a) and blue light (C), and images observed by applying filters under white light (B) and blue light (D). The filters applied here enhance the image for accurate diagnosis.

Statistical analysis:

the malignancy of each detected lesion was determined, 26 cases including 11 lichen planus, 7 leukoplakias, 5 squamous cell carcinomas, 3 oral submucosa fibrosis, and 26 cases were determined to be high-risk lesions.

Sensitivity, specificity, accuracy, positive predictive value and negative predictive value were calculated using the following formulas:

sensitivity [ true positive/(true positive + false negative) ] x100

Specificity ═ true negative/(true negative + false positive) ] x100

Accuracy ═ sensitivity + specificity

Predictive value of positive result (PV +) [ (/, true positive + false positive) ] x100

Predictive value of negative result (PV-) [ true negative/(true negative + false negative) ] xl00

Patient distribution:

and carrying out statistical analysis on the sample distribution. The samples consisted of 50 males and 50 females with an average age of 37-40 years.

The results indicate the occurrence and gender distribution of potential malignant lesions. Clinically undifferentiated lesions were higher in women (90-94%) than in men (86-90%), while clinically differentiated lesions were higher in men than in women (9-10%).

The potential malignant lesions were not statistically different between male and female patients.

As shown in fig. 5 and 6, subject distribution according to lesion type was observed. The data indicate that the highest incidence of traumatic ulcers (26.8%) and or pemphigus vulgaris (1.4%) is the least common.

Other variations will now be apparent to those skilled in the art in view of the foregoing embodiments. Various modifications and variations may be made to the above-described apparatus without departing from the scope of the present invention.

From the foregoing, it will be appreciated that embodiments of the invention described above are well suited to providing the advantages set forth, and that since many possible embodiments may be made of various features of the invention, and since various parts of the apparatus described herein may vary, all without departing from the scope of the invention, it is to be understood that all matter set forth above or shown in the accompanying drawings is to be interpreted as illustrative, and that in some instances, some features may be used without a corresponding use of the other features without departing from the scope of the invention.

Furthermore, the invention must be shown in different figures. The following specific and non-limiting steps for functions should be construed as merely illustrative, and not limitative of the disclosure in any way whatsoever.

Claims (22)

1. A handheld medical device for intraoral screening of an oral cavity, comprising:

a. a power source;

b. a light source for illumination, wherein the light source comprises a plurality of light emitters configured to emit light of a selected wavelength and a selected intensity;

c. an input mechanism for selecting a distribution of the light sources, and selecting a wavelength and an intensity of the light sources;

d. a compute subsystem interfacing the input and output subsystems with the memory subsystem;

e. an image sensing and capturing mechanism for images or video;

f. a data communication subsystem for transmitting data from the device to an external computing system;

g. an electronic wiring mechanism for connecting the computing subsystem to the light source device, the input device, the image sensing and capturing device, the data communication device, and the power supply;

h. a mechanical chassis to enclose the above components.

2. The handheld medical device of claim 1(a), wherein the power source is selected from the group consisting of an external power source or an internal battery or an energy harvesting device.

3. The handheld medical device of claim 1(b), wherein the light source comprises a plurality of light emitters.

4. A light source as claimed in claims 1(b) and 3, wherein the light source comprises a plurality of light emitters, an optional filter for the light emitters, capable of providing a specific wavelength and a specific intensity.

5. The light source according to claim 1(b), preferably implemented using LEDs.

6. The input mechanism of a handheld medical device of claim 1(c), comprising a plurality of switches, each switch having a plurality of positions to select a desired light source distribution to select a wavelength and intensity of light.

7. The input mechanism of a handheld medical device of claim 1(c), comprising wireless means to select a desired light source distribution to select the wavelength and intensity of light.

8. The input mechanism of a handheld medical device of claim 1(c), comprising a wired means to select a desired light source distribution to select the wavelength and intensity of light, provided the device of claim 1 is connected to an external system using a cable.

9. The computing system of a handheld medical device of claim 1(d), comprising a Central Processing Unit (CPU), a memory subsystem, an input/output subsystem, and interfacing with other subsystems of claims 1(a), 1(b), 1(c), 1(e), 1(f), 1 (g).

10. The image sensing and capture mechanism of a handheld medical device of claim 1(e), comprising an image detector with an optical focusing mechanism and an optional filter mechanism on the image sensor.

11. The image sensor of claim 1(e), preferably implemented using a CCD.

12. A filter mechanism according to claims 4 and 10 selectively movable into and out of the optical path in response to the input means.

13. The data communication subsystem of a handheld medical device of claim 1(f), capable of wired communication using an electrical interface, preferably with high data rate, and using any standard protocol from the group of USB, ethernet, firewire.

14. The data communication subsystem of a handheld medical device of claim 1(f), capable of wired communication using a fiber optic interface.

15. The data communication subsystem of a handheld medical device of claim 1(f), capable of wireless communication using any standard protocol from bluetooth, IrDA, wireless LAN, wireless MAN, wireless PAN, cellular communication.

16. The image sensing and capture mechanism of claim 10, data may be stored in the device using the memory subsystem of claim 9, or data may be transmitted out using the data communication subsystem of claim 13.

17. The electronic cabling mechanism of a handheld medical device of claim 1(g), which may be a rigid or flexible-rigid or flexible PCB.

18. The mechanical chassis of a handheld medical device of claim 1(h), which may be rigid or flexible at the proximal end and body of the device.

19. The handheld medical device of claim 1, further comprising at least one selected illumination wavelength located in an illumination light path from the device of claim 1 to a suspect region, and configured to selectively allow light of at least one desired wavelength to be emitted out of a target region.

20. The portable handheld medical device of claim 1, comprising a light source and a camera mechanism for several separate or simultaneous purposes performed by a user for intraoral examination and/or treatment procedures within the oral cavity.

21. A method of remote diagnosis for providing telemedicine services by the handheld medical device of claim 1, comprising:

a. enabling a user of the device of claim 1 to perform a check,

b. connecting a user of the device of claim 1 to an experienced physician over a data communications network, to transmit data from the user to the physician,

c. the user of the device of claim 1 transmits real-time images or video of the patient to the physician via the data communication subsystem,

d. the user of the device of claim 1 transmits the stored image or video of the patient to the physician via the data communications subsystem.

22. A method of screening the oral cavity and diagnosing oral cancer and potential malignant disease by using a hand-held portable intraoral device, wherein the hand-held portable device comprises a light emitting source capable of emitting light of various wavelengths and intensities; an image sensor based camera with an optional filter mechanism; and a data communication subsystem for transmitting image or video data to image or video processing, data recording and display application software on an external computing system.

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